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Since new better drug options had became available, the intervention drug of this study was no longer the best option for the patients. Thus this study was terminated.

Pre-assignment Details

Arm/Group Title

HCV, LT, Pegasys, Ribavirin, Telaprevir

Arm/Group Description

Patients will be treated with Pegyl...

Arm/Group Description

Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.

Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.

To evaluate the efficacy of triple antiviral therapy, consisting of pe...

Description

To evaluate the efficacy of triple antiviral therapy, consisting of pegylated interferon alfa-2a (Pegasys®), ribavirin, and telaprevir therapy in liver transplant recipients with hepatitis C. This will be measured and reported by sustained virologic response (defined as undetectable HCV RNA in the blood 24 weeks after completing therapy [SVR24])

Time Frame

3 years from start of study

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

[Not Specified]

Arm/Group Title

HCV, LT, Pegasys, Ribavirin, Telaprevir

Arm/Group Description:

Patients will be treated with Pegyl...

Arm/Group Description:

Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.

Overall Number of Participants Analyzed

3

Measure Type: Number

Unit of Measure: percentage of participants

100

2.Secondary Outcome

Title

Safety of Triple Antiviral Therapy in HCV Infected OLT Recipients

Description

Tolerability and Safety will be measured and reported by serious adver...

Description

Tolerability and Safety will be measured and reported by serious adverse events.

Time Frame

6 years from the start of the study

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

[Not Specified]

Arm/Group Title

HCV, LT, Pegasys, Ribavirin, Telaprevir

Arm/Group Description:

Patients will be treated with Pegyl...

Arm/Group Description:

Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.

Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.

All-Cause Mortality

HCV, LT, Pegasys, Ribavirin, Telaprevir

Affected / at Risk (%)

Total

--/--

Serious Adverse Events Serious Adverse Events

HCV, LT, Pegasys, Ribavirin, Telaprevir

Affected / at Risk (%)

Total

0/3 (0.00%)

Other (Not Including Serious) Adverse Events Other (Not Including Serious) Adverse Events